Kornimate/medical-research-clean huggingface dataset:
electrophysiologic mapping of the bladder

Conditions: Electrical Evaluation of Urinary Bladder

Summary: the hypothesis is that the intrinsic electrical activity of the urinary bladder in response to filling is detectable and can be mapped. this is a pilot study to evaluate the feasibility of using cardiac electrical mapping catheters to measure bladder voltage in patients at the time of routine urodynamic and cystoscopic evaluation.

this pilot study is looking at the possibility of adapting some of the tools and techniques used by cardiac electrophysiologists (doctors specializing in the electrical activity of the heart) to help diagnose and treat overactive bladder. the rationale for this approach is based on the similarities of the two organs. in simple terms, the heart and bladder are both hollow muscular organs that expand and contract to hold and move fluid. in an electrophysiology study looking at cardiac (heart) arrhythmia (irregular heartbeat), the cardiologist places one or more electrode catheters (thin hollow tube with an electrical conductor on the end) through a vein or artery in the leg or arm to contact heart tissue. by recording the electrical activity at multiple sites of the heart, the catheter allows for mapping of the electrical activity and the arrhythmia mechanism. in this study, investigators will use the same electrode catheter to contact bladder tissue, introduce a low frequency current, and map the electrical activity of the bladder. a sterile cardiac electrical mapping catheter will be used to make contact with the walls of the bladder and introduce a low frequency current starting with the trigone and then the four quadrants of the dome. electrical activity will be recorded for each volumetric milestone at each location. it is hoped that the information from this electrophysiological testing of the bladder may eventually lead to treatment of areas of electrical abnormality of interest. no actual treatment of the bladder will be done as part of this pilot study.

Eligibility criteria:
inclusion criteria: * subject is a female \> = 18 years old. * subject is willing and able to provide informed consent. * subject has subjective and objective evidence for urinary urgency (with or without incontinence), stress incontinence, or mixed incontinence (with features of both urgency and stress). * subject requires urodynamic/cystoscopic studies to complete their workup. exclusion criteria: * active urinary tract infection * pregnant women * patients on anticholinergic medicine for overactive bladder * patients with history of intravesical botulinum toxin injections * patients with a sacral neuromodulator implant * patients with a history of urinary tract malignancy

Keywords: overactive bladder cystoscopy
mitiglinide in combination with metformin vs. metformin alone in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with type 2 diabetes mellitus (t2dm) whose blood sugar is not well controlled taking metformin alone. this is a 24 week study which measures improvement in blood sugar after of treatment.

this is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with t2dm who are less than adequately controlled on metformin alone. patients who are receiving metformin alone for t2dm will be randomized equally into one of three treatment groups.

Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed for at least 6 months * stable metformin usage for at least 4 months * hba1c 7.5% - 10.5% inclusive * no severe diabetic complications exclusion criteria: * chronic insulin use * use of oral diabetic agent within 12 weeks * acute or chronic conditions, excluding diabetes, that could compromise end point evaluation
the impact of alna® ocas® on nocturia in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (luts/bph)

Conditions: Prostatic Hyperplasia

Summary: study to assess efficacy, tolerability and safety parameters of a three month alna®ocas® -treatment with special respect to nocturia


Eligibility criteria:
inclusion criteria: * indication for treatment with alna®ocas® according to the prescribing information for a minimum period of three months exclusion criteria: * patients fulfilling one of the general or specific contraindications listed in the alna®ocas® summary of product characteristics (spc), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the post marketing study (pms) study
association of the risk for thrombotic thrombocytopenia syndrome and exposure to covid-19 vaccines

Conditions: Covid-19

Summary: background/rationale: a very rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to covid-19 vaccine. this thrombotic thrombocytopenia syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors. objectives: to evaluate an association between covid-19 vaccine exposure and thromboembolic events occurring with thrombocytopenia (thrombotic thrombocytopenia syndrome; tts). study design: two primary study designs will be considered, a case control study and a self-controlled case series (sccs). a cohort analysis will be considered, in addition or as an alternative to either of the primary study designs, pending feasibility assessment of the follow-up time. data source(s): data for the study will be accessed through the nhs digital trusted research environment (tre), providing national data coverage. primary care data will be linked with vaccination, hospitalization, covid-19 test results, mortality data. initial exploratory analyses will be conducted using the oxford-royal college of general practitioners sentinel network; orchid network database (n\>15million). subjects of interest are patients who have received a covid-19 vaccine. however, investigators will require access to data from all subjects in the databases. statistical analysis: the study period will start on december 02, 2020, when the covid-19 vaccine was first approved in the uk and will end at the end of data availability. for the case-control design, all cases of tts will be matched with control using risk-set matching. a case or matched control will be considered exposed if a covid-19 vaccination will be within risk interval prior to the diagnosis date of the matched case. for the sccs, estimates of relative incidence (ri), in all risk intervals will be reported. for the retrospective cohort design, the incidence of tts after receiving covid-19 vaccine will be estimated and investigators will compare this incidence with that occurring in an unvaccinated comparator group about levels of infection across the whole population. variables: demographic, socioeconomic descriptors, clinical diagnosis, vaccines, potential confounders, thrombotic phenomena, covid-19 infection, and other characteristics as applicable.


Eligibility criteria:
inclusion criteria: * a minimum of 12 months medical history prior to the start of the study period exclusion criteria: * less than 12 moths medical history prior to the start of the study period
ih convidecia as second booster dose against breakthrough infections

Conditions: COVID-19

Summary: this will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of ih convidecia (cansino), as a second booster vaccination against omicron and other emerging vocs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose. these subjects will be randomized in a ratio of 1:1 to receive a second booster dose of ih convidecia vaccine (treatment arm), or a second booster dose of mrna vaccine bnt162b2 (pfizer).


Eligibility criteria:
inclusion criteria: * participant is willing and able to give written informed consent for participation in the study. * male or female, aged 18 years or above and in good health as determined by study clinician. participants may have well controlled or mild-moderate comorbidity. * female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation. * in the investigator's opinion, participant is able and willing to comply with all trial requirements. * at least 16 weeks after first booster dose of vaccination. exclusion criteria: * confirmed cases, suspected cases or asymptomatic cases of covid-19. * self-reported history of sars and mers infection. * receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination. * receipt of any sars-cov-2 vaccine after first dose of booster vaccination. * participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination. * administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines. * history of allergic disease or reactions likely to be exacerbated by any component of study vaccines. * any history of anaphylaxis. * bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following im injections or venipuncture. * suspected or known current alcohol or drug dependency. * any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. * severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed). * participant with life expectancy of less than 6 months.

Keywords: inhaled convidecia safety immunogenicity
safety and efficacy study of asfotase alfa in severely affected infants with hypophosphatasia (hpp)

Conditions: Hypophosphatasia (HPP)

Summary: this clinical trial studies the safety and efficacy of asfotase alfa in infants and young children with infantile onset hpp.

hypophosphatasia (hpp) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. there are no approved disease-modifying treatments for patients with this disease. there is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria:
inclusion criteria: * legal guardian(s) must provide informed consent prior to any study procedures * documented diagnosis of severe hpp as indicated by: * total serum alkaline phosphatase at least 3 standard deviations (sd) below the mean for age * plasma pyridoxal 5'-phosphate (plp) at least 4 times the upper limit of normal * radiographic evidence of hpp (hypophosphatasia), characterized by: * flared and frayed metaphyses * severe, generalized osteopenia * widened growth plates * one or more hpp-related findings: * history or presence of: * non-traumatic post-natal fracture * delayed fracture healing * history of elevated serum calcium * functional craniosynostosis with decreased head circumference growth * nephrocalcinosis * respiratory compromise * rachitic chest deformity and/or vitamin b6 dependent seizures * failure to thrive * onset of symptoms prior to 6 months of age * age ≤ 36 months * otherwise medically stable (patient may be on ventilatory support) * legal guardian(s) must be willing to comply with the study exclusion criteria: * history of sensitivity to any of the constituents of the study drug * current or prior clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, infectious, urologic, pulmonary, neurologic, dermatologic, renal condition and/or other major disease which, in the opinion of the investigator, precludes study participation * treatment with an investigational drug within 1 month prior to the start of study drug administration * current enrollment in any other study involving an investigational new drug, device or treatment for hpp (e.g., bone marrow transplantation) * low serum calcium, phosphate or 25(oh) vitamin d * current evidence of a treatable form of rickets * prior treatment with bisphosphonate

Keywords: hypophosphatasia hpp bone disease soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase tissue non-specific alkaline phosphatase rickets osteomalacia
fet-pet/mri based treatment planning for glioblastoma multiforme in post-surgical patients (fet-treat)

Conditions: Glioblastoma Multiforme

Summary: glioblastoma multiforme (gbm) represent the most common primary brain malignancy and prognosis remains poor. the most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. despite advances in mri techniques, accurately determining total extent of tumor remains a challenge. the result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. a more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.


Eligibility criteria:
inclusion criteria: each participant must meet all of the following inclusion criteria to participate in this study: * ≥ 18 years of age * diagnosis of glioblastoma multiforme * post-maximally safe surgical resection * no prior radiation or systemic treatment for high grade glioma * able to tolerate pet/mri scan with intravenous contrast * willing to provide informed consent exclusion criteria: all participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study: * mri contraindication * creatinine clearance \< 30ml/min * inability to lie still for 60 minutes * gadolinium allergy * positive pregnancy test * breastfeeding * patient unable to follow the protocol for any reason

Keywords: fet-pet glioblastoma gbm 0-(2-18f-fluoroethyl)-l-tyrosine (fet) glioma
antioxidant vitaminas and hypertrophy adaptations to resistance training

Conditions: Hypertrophy

Summary: this investigations aims to investigate whether supplementation with antioxidant vitamins (vitamin c and vitamin e) can influence, enhancing or blocking, the hypertrophic adaptations caused by strength training in sedentary subjects.

a randomized, double-blind, placebo-control controlled trial will be conducted. in a previous session volunteers will be interviewed to determine if they meet the inclusion criteria. will be done two weeks of flushing out other types of supplementation and strenuous physical exercise, along with familiarization with the strength training program and performance tests to be carried out during the rehearsal. subsequently, it will be a week without exercising to start with the experimental designs. from the start of the trial, participants should avoid physical exercise. strenuous outside the training protocol and if usual, they will only be able to perform one resistance training session per week. participants should avoid ingesting of foods that contain high amounts of antioxidant compounds: more than two juices of fruits, more than four cups of coffee or tea. juices with high antioxidant content should be avoided. alcoholic beverages should also be avoided. * group 1 (g1): antioxidant vitamins (vitc (1000 mg) + vite (235 mg)) + exercise * group 2 (g2): placebo + exercise a supplementation period of 12 weeks will be carried out. in each period, supplementation with antioxidant vitamins: vitc (1000 mg) + vite (235 mg) or with placebo. all participants will ingest the supplementation between 1-3 hours before training, the days of rest in the mornings. all participants will perform a 12-week strength training protocol. the training session performed in the sharp design will be the first training session in chronic design. being the baseline (e0) and post-exercise (e1) assessment performed in g1, g2 and g3 also the first evaluation corresponding to the chronic design. in the middle of the supplementation period (week 6) and at the end, two new evaluations (week 12). baseline evaluations will be performed prior to an exercise session of week 6 (e2) and at the last exercise session (e3) of the following parameters: performance physique, body composition, micronutrient analysis, muscle ultrasound. i also know conduct post-exercise physical performance assessments figure 2. the strength training protocol will be carried out 4 days a week at the facilities sports of the european university. the sessions will be planned by a professional from the sciences of physical activity and sports. sessions will be tracked through a diary.

Eligibility criteria:
inclusion criteria: * experience in strength training of at least one year exclusion criteria: * smokers * antioxidant supplementation * injuries or diseases
fractures of the humeral shaft with primary radial nerve palsy

Conditions: Radial Nerve Palsy; Functional Outcome

Summary: this study addresses the question if patients with fractures of the humeral shaft and primary radial nerve palsy gain nerve recovery. additionally the influence of injury mechanism, fracture type, and treatment modality on nerve recovery should be evaluated.

adult fractures of the humeral shaft account for approximately 3% of all fractures; most can be treated nonoperatively. due to the anatomy of the radial nerve and the entrapment between fragments in spiral fractures of the humerus, these injuries are associated with primary radial nerve palsy in up to 18%. therefore, the purpose of this study was to assess the influence of injury mechanism, fracture type, and type of surgical treatment on time to onset of nerve recovery and time to full nerve recovery in patients with humeral shaft fractures and concomitant primary radial nerve palsy. a retrospective analysis of prospectively collected data for all patients treated with humeral shaft fracture and primary radial nerve palsy at an academic level-i trauma center was performed. between 1994 and 2013 a total of 615 patients with traumatic humeral shaft fractures were treated at the department. the dataset was examined for completeness and accuracy. patients with an incomplete dataset, those with a pathologic or periprosthetic fracture, patients with non-surgical treatment, or who were younger than 18 years of age were excluded from this series. according to these criteria, a total of 50 patients with a humeral shaft fracture and primary radial nerve underwent surgical treatment

Eligibility criteria:
inclusion criteria: * patients treated with humeral shaft fracture and primary radial nerve palsy between 1994 and 2013 at the department of trauma surgery, medical university of vienna * surgical treatment * complete data sets * minimum 18 years of age exclusion criteria: * patients with an incomplete dataset * those with a pathologic or periprosthetic fracture * patients with non-surgical treatment * or who were younger than 18 years of age

Keywords: intramedullary nailing orif humeral shaft fracture
adrabetadex to treat niemann-pick type c1 (npc1) disease

Conditions: Niemann-Pick Disease, Type C

Summary: due to different study designs, the sponsor separated part c into this separate registration (nct04958642), leaving parts a/b in nct02534844. the trial's final results for the primary outcome measure of adverse events (ae) will be reported here. this study is to evaluate how safe and effective adrabetadex is for participants with niemann-pick type c1 (npc1) disease who experience neurologic symptoms (listed under keywords). in parts a/b (nct02534844), two out of every 3 participants will receive the study drug. the third participant will receive 1 to 2 small needle pricks at the location where the it injection is normally made (sham control). in part c, all participants will receive study drug.

participants in part c will receive adrabetadex until the investigator considers adrabetadex to no longer be beneficial to the participant, or the development program is discontinued.

Eligibility criteria:
inclusion criteria: one of the following is required for inclusion into vts301 part c: * has agreed to convert from the monthly dosing regimen used in the nih phase 1/2a protocol to an every 2 weeks dosing regimen * the investigator has received prior written authorization from the sponsor for the participant to enter vts301 part c on an amended dose and/or regimen * has received prior written authorization from vtesse to enroll directly into part c exclusion criteria: * none of the inclusion criteria are applicable

Keywords: niemann-pick type c1 (npc1) disease neurologic disease gross motor dysfunction fine motor dysfunction dysphagia swallowing problems cognitive dysfunction gait abnormalities pediatrics